BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2191853 · Received July 22, 2011

    Report

    Report Number
    1644487-2011-01668
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NURSE THAT SHE FOUND A "BROKEN WIRE" ON A VNS PT. THE PT VISITED THE NURSE IN CLINIC AND UPON INTEGRATION OHMS WERE ABOVE 10,000. THE NURSE REFERRED THE PT FOR X-RAYS AND DID NOT PROGRAM THE PT'S VNS OFF AS RECOMMENDED BY THE MFR DUE TO CAREGIVERS NOT WANTING THE DEVICE OFF. FURTHER INFO WAS RECEIVED FROM THE TREATING NURSE INDICATING THAT X-RAYS ARE PLANNED BUT WILL NOT BE PROVIDED TO THE MFR DUE TO PT CONFIDENTIALITY. NO PT TRAUMA OR MANIPULATION WAS REPORTED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. AT THE MOMENT, NO INTERVENTIONS HAVE BEEN PLANNED FOR THE PT; HOWEVER, THE PT WILL BE REVISED WITHIN 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR